The Recall Desk
SevereFDA (Devices)·Z-0064-2019·Announced 2018-10-10

Leica HistoCore SPECTRA ST Slide Stainer Recalled for Electrical Safety Hazard

Leica Microsystems is recalling 67 automated slide stainers because a single fault could expose users to hazardous mains voltage.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural electrical defect that could expose users to hazardous mains voltage, meeting the rubric criteria for a structural defect or significant injury risk.

Plain-English summary

Leica Microsystems, Inc. is recalling 67 units of the Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated. This device is intended for laboratory applications to prepare histological and cytological specimens. The recall involves serial numbers 70-78, 111-112, and 120-175.

The recall was initiated because the devices have an incorrect specification against the safety standard ISO61010-1. If a single fault error occurs, a mains wire can contact a metal plate that is accessible to the user. This could result in hazardous voltage on the metal plate, posing an electrical shock risk to the user.

The affected units were distributed nationwide to Arizona, California, Colorado, Kansas, Massachusetts, the Marshall Islands, Missouri, New Jersey, Ohio, and Wisconsin. They were also distributed worldwide to Canada, China, Germany, Great Britain, Japan, and Switzerland. Users should contact Leica Microsystems for instructions on how to resolve the safety issue.

The recalled product

Product
Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
Affected units
67

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Serial Numbers: 70-78
  • 111-112
  • 120-175

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically: